Research Do Not Contact

Patient data may be used for clinical research pursuant to IRB approval. For studies that involve any level of patient contact; recruitment messaging, text messaging, nudges, consent administration, questionnaires, etc. “Research Do Not Contact” patients must be removed from any data set. This includes studies which involve a waiver of consent and authorization for a subset of the study and have subsequent patient contact in of any form. The approval for a waiver of consent and authorization by the IRB, alone,  does not permit the use of Research Do Not Contact patients. If there is any contact intended, these patients need to be excluded.

Research approved that does not involve patient contact may include “Research Do Not Contact” patients in the data set. This would include secondary data analysis, longitudinal studies, biospecimen studies with no contact, etc. For some studies it may be appropriate to include Research Do Not Contact Opt Outs in a primary dataset and then they may need to be exclude from subsequent uses that involve contact in the research study.